NOVEL ONCE DAILY ANTI-EPILEPTIC ZEBINIX® APPROVED IN THE EUROPEAN UNION

- NEW OPTION FOR TREATMENT OF EPILEPSY PATIENTS WITH PARTIAL ONSET SEIZURES

Bial-Portela & CA, S.A., (S. Mamede do Coronado, Portugal, President & CEO Dr Luis Portela), and Eisai Europe Limited (London; Chairman & CEO Yutaka Tsuchiya), the European subsidiary of Eisai Co., Ltd. (Tokyo, President & CEO: Haruo Naito), today announced that the novel once daily anti-epileptic Zebinix®* (eslicarbazepine acetate) received marketing authorisation from the European Commission as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation. 

Epilepsy is one of the most common neurological diseases, affecting approximately 1 in 100 people.

Treatment of partial-onset seizures, the most common type of epilepsy, remains a constant challenge and up to 40% of patients with partial seizures do not achieve seizure control with current anti-epileptics1.

The efficacy, safety and tolerability of eslicarbazepine acetate (ESL) has been demonstrated in three phase III double-blind, randomised placebo-controlled trials in 1,049 patients with partial onset seizures2-4. For each randomised control trial patients were given the option of entering a one year open label extension study.

ESL demonstrated significant and sustained reductions in seizure frequency and significant increases in responder rates (≥50% decrease in seizure frequency.) These studies also demonstrated that patients continued to take ESL with retention rates ranging from 68-79% at one year5-7. The median daily dose throughout this one year treatment was 800mg. Treatment-emergent adverse events affecting >10% of patients in the pivotal studies were dizziness, headache and somnolence8.

The studies found that patients taking Zebinix® also showed statistically significant improvement in scores of health related quality of life measures such as reduced 'seizure worry', improvements in 'cognitive functioning' and reduced 'medication effects', all factors which significantly affect the lives of patients living with epilepsy.9-11

Zebinix® can be given as a true one tablet once a day regimen at its median daily dose as defined in clinical trials as 800mg 5-7. It works by selectively inhibiting the rapid firing of neurones. Zebinix® interacts with site two of the voltage-gated sodium channel, stabilising its inactive form and preventing its return to the active open state, thereby reducing repetitive neuronal firing. Zebinix® has a much higher affinity for the inactivated state of the channel compared with the resting state which means it is less likely to interfere with normal neuronal function 12.

"A significant number of patients with partial-onset seizures remain uncontrolled on existing epilepsy therapies and the inability to control seizures can have a devastating impact on the quality of a patient's day to day life and functioning," said Professor Christian Elger, Director and Head of the Department of Epileptology at the University of Bonn, Germany and the lead author of one of the pivotal studies - published earlier this year in Epilepsia.

Under the terms of a deal with Bial announced in February this year, Eisai received a sole license to market, promote and distribute Zebinix® within Europe**.

"The EU approval of Zebinix® represents a significant milestone for Bial in our efforts to bring this novel treatment to patients with partial-onset seizures", said Luís Portela, President and Chief Executive Officer of Bial. "We will work closely with our European partner Eisai to launch Zebinix® across the EU during 2009 and into 2010." 

Yutaka Tsuchiya, Chairman & CEO of Eisai Europe said "The effective treatment of patients with partial-onset seizures remains a major challenge for clinicians and the carers of patients with epilepsy, and we are delighted to be working with Bial towards bringing to patients such a promising new treatment for epilepsy. Zebinix® joins our existing family of anti-epileptics, which includes Zonegran® zonisamide and Inovelon® rufinamide and a new molecule currently entering phase three clinical development studies. When launched, Zebinix® will help us to fulfil our Corporate mission of ‘human health care' (hhc).

FOR FURTHER INFORMATION PLEASE CONTACT

Francisco Osório, BIAL

+351 22 9866100

+351 96 346 9968


Andrew Day, EISAI

+44 (0)20 8600 1400

+44 (0)7973 411 419 

Christer Ahlberg, Nordic Managing Director, Eisai AB

Phone: +46 8 501 01 610, Cell Phone: +46 70 675 33 30,

E-Mail: christer_ahlberg@eisai.net

FOR MEDICAL INFORMATION PLEASE CONTACT

Sten Friberg, Nordic Medical Director, Eisai AB

Phone: +46 8 501 08 681, Cell Phone: +46 70 564 64 54,

E-Mail: sten_friberg@eisai.net

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